The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Device Description

The Xpeed AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. The fixtures are made from CP Ti Grade 4, and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The fixtures are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The fixture is used as two stages, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. This system has 4.0, 4.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the "Xpeed AnyRidge Internal Implant System." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria, as one would find for a de novo device or a device requiring a PMA.

Therefore, the document does not report specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device or a pass/fail threshold for a functional characteristic based on a clinical outcome. It also does not describe a study designed to prove the device meets such acceptance criteria based on its direct performance.

Instead, the document focuses on demonstrating that the modifications made to the manufacturing process do not affect the substantial equivalence of the subject device to its predicate devices. The "acceptance criteria" discussed are primarily related to general device characteristics and compliance with standards.

Here's an analysis based on the information provided, recognizing that the scope of this document is different from a typical performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, there are no statistical performance metrics (e.g., accuracy, sensitivity, specificity) or specific quantitative clinical "acceptance criteria" presented for the Xpeed AnyRidge Internal Implant System. The "performance" assessment is based on demonstrating that the manufacturing process modifications do not alter the established characteristics of the device compared to its predicates.

Therefore, a table of this nature cannot be generated from the provided text. The document lists tests performed and states that results met the criteria of the standard, which serves as a general statement of acceptance for each test.

Test Item	Acceptance Standard/Criteria	Reported Device Performance
Appearance	In-house standard	Met the criteria of the standard
Dimension	In-house standard	Met the criteria of the standard
Packaging	ISO 11607	Met the criteria of the standard
Extraction	USP <711>	Met the criteria of the standard
Sterility	USP <71>	Met the criteria of the standard
Biocompatibility (Acute systemic toxicity)	ISO 10993-11	Non-clinical testing results demonstrate substantial equivalence to predicate device
Biocompatibility (Sensitization)	ISO 10993-10	Non-clinical testing results demonstrate substantial equivalence to predicate device
Biocompatibility (Cytotoxicity)	ISO 10993-5	Non-clinical testing results demonstrate substantial equivalence to predicate device
Biocompatibility (Intracutaneous reactivity)	ISO 10993-10	Non-clinical testing results demonstrate substantial equivalence to predicate device
Biocompatibility (Implantation)	ISO 10993-6	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface analysis (XPS)	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface analysis (EPMA)	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface analysis (XRD)	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface analysis (ICP)	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface analysis (SEM)	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device
Surface roughness	In-house standard	Non-clinical testing results demonstrate substantial equivalence to predicate device

2. Sample Size Used for the Test Set and Data Provenance

The document describes "non-clinical test data" which includes appearance, dimension, packaging, extraction, sterility, biocompatibility, and surface analysis tests.

Sample Size: The specific sample sizes for these tests are not provided in the document.
Data Provenance: This refers to in-vitro/bench testing ("in-house standard," ISO standards, USP standards). It is not clinical data (e.g., patient data). The country of origin for the data is not explicitly stated beyond the manufacturer being in South Korea. This is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the tests described are non-clinical, bench-top tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are non-clinical, bench-top tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human readers or expert consensus on patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is an endosseous dental implant system, not a diagnostic AI device that involves human readers or assessment of AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to the specified criteria or limits defined by the referenced standards (e.g., ISO 11607 for packaging, USP <711> for extraction, ISO 10993 series for biocompatibility, and in-house standards for others). There is no "expert consensus, pathology, or outcomes data" in the clinical sense for these bench tests.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As mentioned above, this document does not describe the development of an AI/ML model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12,2014

MegaGen Implant Company, Limited C/O Ms. Minkyung Hahm Contact/US Agent Kodent, Incorporated 325 North Puente Street, Unit B Brea, California 92821

Re: K140091

Trade/Device Name: Xpeed AnyRidge Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 4, 2014 Received: November 4, 2014

Dear Ms. Hahm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Ms. Hahm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Page 3 – Ms. Hahm

{3}------------------------------------------------

Indication for Use

510(K) Number (if known):

Device Name: Xpeed AnyRidge Internal Implant System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Sub part D)

AND/OR

Over The-Counter Use (21 CFR 807 Sub part C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{4}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter:

Dong Guk Ha MegaGen Implant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432

Contact /US agent: Minkyung Hahm KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116

Device Information:

Device Name: Xpeed AnyRidge Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date Prepared: 3/24/2014

Device Description

The purpose of this submission is

to modify the manufacturing process of the fixtures that was mistakenly documented under 510(k) number K122231.

Indication for use

{5}------------------------------------------------

good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Predicate devices

AnyRidge Internal Implant System (K110955)
Straumann Anodized Neck Implants (K061176) .

Substantial Equivalence Comparison

The Xpeed AnyRidge Internal Implant System has a substantially equivalent intended use as the identified predicate. The Xpeed AnyRidge Internal Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium. The subject and predicate device are same in size and materials. When compared with predicate device, no new questions of substantial equivalence have been raised for the Xpeed AnyRige Internal Implant System.

	Subject Device	Predicate Device
510(k) Number	Not available yet	K110955	K061176
Device Name	Xpeed AnyRidgeInternal ImplantSystem	AnyRige InternalImplant System	Straumann AnodizedNeck Implants
Manufacturer	MegaGen Implant Co.,Ltd	MegaGen Implant Co.,Ltd	Straumann
Indications for Use	Mandible and MaxillaEndosseous DentalImplant & Accessories	Mandible and MaxillaEndosseous DentalImplant & Accessories	Mandible and MaxillaEndosseous DentalImplant
Design	Xpeed AnyRidgeInternal ImplantSystem, abutments andaccessories have beendesigned, manufacturedand tested incompliance withFDA's Class II specialcontrols guidancedocument root-formendosseous dentalimplants andendosseous dentalimplant abutments	AnyRidge InternalImplant System,abutments andaccessories have beendesigned, manufacturedand tested incompliance with FDA'sClass II special controlsguidance documentroot-form endosseousdental implants andendosseous dentalimplant abutments	-Single-stageor two-stage- Single-tooth and/ormultiple toothapplications-Neck diameter :3.5mm, 4.8mm
Material	CP Ti Grade 4	CP Titanium, Gr.4 andTi-6Al-4V, ELI	CP4 Titanium
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Fixture Diameter	Internal type4.0, 4.4, 4.9, 5.4,5.9mm(For normal ridge)6.4, 6.9, 7.4, 7.9,8.4mm	Internal type4.0, 4.4, 4.9, 5.4,5.9mm(For normal ridge)6.4, 6.9, 7.4, 7.9,8.4mm	3.3, 4.1, 4.8mm

{6}------------------------------------------------

Fixture Height	Internal type7.7, 9.2, 10.7, 12.2,14.2, 17.2mm(For normal ridge)7.9, 9.4, 10.9, 12.4,14.4mm(For low ridge)	Internal type7.7, 9.2, 10.7, 12.2,14.2, 17.2mm(For normal ridge)7.9, 9.4, 10.9, 12.4,14.4mm(For low ridge)	8, 10, 12, 14mm
Product Code	DZE, NHA	DZE	N/A
Surface treatment	SLA	SLA	N/A

Non-Clinical Test Data

Appearance, Dimension, Packaging, Extraction, and Sterility tests were performed to prove that the modification do not affect the substantial equivalence with the predicate device.

Appearance and Dimension test have been performed in accordance with the in-house standard and Packaging test has been performed in accordance with ISO 11607. Those tests have been performed to evaluate the substantial equivalence in size and packaging compared to the predicate device.

Extraction and sterility test have been performed in accordance with USP<711> and USP<71>.

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device.

The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device.

Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

	Testing Item	References
Biocompatibility test	Acute systemic toxicity test	ISO 10993-11
	Sensitization test	ISO 10993-10
	Cytotoxicity	ISO 10993-5
	Intracutaneous reactivity test	ISO 10993-10
	Implantation test	ISO 10993-6
Surface analysis	XPS	In-house standard
	EPMA	In-house standard
	XRD	In-house standard
	ICP	In-house standard
	SEM	In-house standard
	Surface roughness	In-house standard

The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification concludes that the Xpeed AnyRidge Internal Implant system is substantially equivalent to predicate devices as described herein.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.